Stricter standards for India’s clinical drug trials
Following allegations against pharmaceutical multinational companies (MNC’s) for using humans as guinea pigs to conduct illegal clinical trials, India’s Supreme Court has ordered that all clinical drug trials be performed under the Centre Health Secretary. Earlier this month, the apex court accused the Health Ministry of ignoring the issue and failing to put proper mechanisms in place to control illegal trials that have caused the deaths of more than 2,242 deaths in the last five years. The court slammed the government’s past attempts to crack down on the various pharmaceutical companies, saying little had been done to remedy the problem, and gave the Ministry four weeks to address to the matter. The bench did, however, refrained from passing any blanket ban on the trials and, instead, sought a comprehensive reply from the Centre on various issues.
In response, the government said it plans to regulate the $500 million sector by amending drug laws to include stricter guidelines for pharma MNC’s and increasing compensation payments to subjects. The new rules are expected to be outlined later this month, and will further amend clinical trial laws under the Drug and Cosmetics Act to make errors by pharma MNC’s punishable by offense under law. The regulations put specific responsibilities on investigators and sponsors of the trials as well, in order to guarantee that subjects involved in the trials receive adequate medical care and treatment. In addition, the laws will prescribe a new formula for a fixed minimum compensation amount, as well as increased rates in cases of accidents and death. In the past, Indian participants sometimes received as little as 50,000 rupees, or about $917 total, in cases of death during a trial.
The government also promised to set up a system of stronger ethics committees under medical institutes to monitor ongoing trials in India. These committees must be registered with the Drug Controller of India prior to the start of any trial.
It is important to note that insurance for Clinical Trials is not compulsory in India. However, if a sponsor wishes to rely on an insurance policy to pay for damages/injuries to research subjects participating in the study, then the clinical trial policy must be written with local Indian insurers such as, Bajaj Allianz, ICICI Lombard or New India Assurance.
Coverage is available on either a “No-Fault” or “Legal Liability” basis. A “No-Fault” policy will compensate research subjects for their injury without the necessity of legal proceedings, where as a “Legal Liability” policy will provide compensation to a third-party as imposed on the insured by court judgment.
About the Author
Priscilla Walsh is a Vice President at WGA and specializes in the Life Sciences industry as well as Foreign Clinical Trial placements.